CN117940183A

CN117940183A - Positioning and stabilization structure for patient interface

Info

Publication number: CN117940183A
Application number: CN202280062400.8A
Authority: CN
Inventors: 托恩蒂拉·素帕奥帕斯蓬; 莫汉库马尔·克里希南·瓦利扬巴思; 陈邦正
Original assignee: Rysmay Asia Private Ltd
Current assignee: Rysmay Asia Private Ltd
Priority date: 2021-09-17
Filing date: 2022-09-16
Publication date: 2024-04-26
Also published as: WO2023043377A2; WO2023043377A3

Abstract

A positioning and stabilizing structure for a patient interface, the headgear section comprising a first headgear section and a second headgear section, wherein the first headgear section and the second headgear section are connected by a seamless joint comprising at least one polymer layer spanning between and applied to the first headgear section and the second headgear section.

Description

Positioning and stabilization structure for patient interface

1 Background Art

1.1 Technical field

The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and amelioration of respiratory-related disorders. The present technology also relates to medical devices or apparatus and uses thereof.

1.2 Description of related Art

1.2.1 Human respiratory System and disorders thereof

The respiratory system of the human body promotes gas exchange. The nose and mouth form the entrance to the patient's airway.

The airways include a series of branches that become narrower, shorter and more numerous as the branch airways penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to enter venous blood from the inhaled air and to expel carbon dioxide in the opposite direction. The trachea is divided into left and right main bronchi, which are ultimately subdivided into end bronchioles. The bronchi constitute the conducting airways, but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lung is the region where gas exchange occurs and is referred to as the respiratory region. See, respiratory physiology (Respiratory Physiology), 9 th edition published by John b.west, lippincott Williams & Wilkins in 2012.

1.2.2 Treatment

Various respiratory therapies, such as Continuous Positive Airway Pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive Ventilation (IV), and High Flow Therapy (HFT), have been used to treat one or more of the respiratory disorders described above.

1.2.2.1 Respiratory pressure treatment

Respiratory pressure therapy is the application of air supplied to the entrance of the airway at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as a tank or chest-type ventilator).

1.2.3 Respiratory therapy System

These respiratory treatments may be provided by a respiratory treatment system or device. Such systems and devices may also be used to screen, diagnose, or monitor a condition without treating it.

The respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

1.2.3.1 Patient interface

The patient interface may be used to couple the breathing apparatus to its wearer, for example by providing an air flow to the inlet of the airway. The air flow may be provided to the patient's nose and/or mouth via a mask, to the mouth via a tube, or to the patient's airway via an aerocut tube. Depending on the treatment applied, the patient interface may form a seal with, for example, an area of the patient's face to facilitate delivery of gas at a pressure that is sufficiently different from ambient pressure to effect the treatment, for example, at a positive pressure of about 10cmH ₂ O relative to ambient pressure. For other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of the gas supply to the airway at a positive pressure of about 10cmH ₂ O. For flow therapies such as nasal HFT, the patient interface is configured to insufflate the nostrils, but specifically avoids a full seal. One example of such a patient interface is a nasal cannula.

Some other mask systems may not be functionally suitable for use in the art. For example, a purely cosmetic mask may not be able to maintain a suitable pressure. Mask systems for underwater swimming or diving may be configured to prevent ingress of water at higher pressure from the outside, but not to maintain the internal air at a pressure above ambient pressure.

Certain masks may be clinically disadvantageous to the present technique, for example, where they block airflow through the nose and only allow airflow through the mouth.

If some masks require a patient to insert a portion of the mask structure into their mouth to form and maintain a seal via their lips, these masks may be uncomfortable or impractical for the present technology.

Some masks may not be practical for use while sleeping, such as when the head is lying on the side on a pillow and sleeping in a bed.

The design of patient interfaces presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from individual to individual. Since the head includes bone, cartilage, and soft tissue, different regions of the face react differently to mechanical forces. The mandible or mandible may be moved relative to the other bones of the skull. The entire head may be moved during the respiratory treatment period.

Because of these challenges, some masks face one or more of the following problems: abrupt, unsightly, expensive, incompatible, difficult to use, especially when worn for extended periods of time or uncomfortable for the patient when not familiar with the system. Wrong-sized masks may result in reduced compliance, reduced comfort, and poor patient prognosis. Masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for applying anesthetic agents are acceptable for their original application, but such masks may be uncomfortable to wear for extended periods of time (e.g., hours). Such discomfort may lead to reduced patient compliance with the treatment. This is especially true if the mask is worn during sleep.

CPAP therapy is very effective in treating certain respiratory disorders, provided that the patient is compliant with the therapy. If the mask is uncomfortable or difficult to use, the patient may not be compliant with the treatment. Since patients are often advised to regularly clean their masks, if the masks are difficult to clean (e.g., difficult to assemble or disassemble), the patients may not clean their masks, which may affect patient compliance.

While masks for other applications (e.g., pilots) may not be suitable for treating sleep disordered breathing, masks designed for treating sleep disordered breathing may be suitable for other applications.

For these reasons, patient interfaces for delivering CPAP during sleep form a unique field.

1.2.3.1.1 Seal forming structure

The patient interface may include a seal-forming structure. The shape and configuration of the seal-forming structure may directly affect the effectiveness and comfort of the patient interface because of its direct contact with the patient's face.

The patient interface may be characterized in part by the design intent of the seal-forming structure to engage the face in use. In one form of patient interface, the seal-forming structure may include a first sub-portion that forms a seal around the left naris and a second sub-portion that forms a seal around the right naris. In one form of patient interface, the seal-forming structure may comprise a single element that, in use, surrounds both nostrils. Such a single element may be designed to cover, for example, the upper lip region and the nasal bridge region of the face. In one form of patient interface, the seal-forming structure may comprise an element that in use surrounds the mouth region, for example by forming a seal on the lower lip region of the face. In one form of patient interface, the seal-forming structure may comprise a single element that in use surrounds both nostrils and the mouth region. These different types of patient interfaces may be variously named by their manufacturers, including nasal masks, full face masks, nasal pillows, nasal sprays, and oral nasal masks.

A seal-forming structure that may be effective in one region of a patient's face may not fit in another region, for example, because of the differences in shape, structure, variability, and sensitive areas of the patient's face. For example, a seal on swimming goggles covering the forehead of a patient may not be suitable for use over the nose of a patient.

Some seal-forming structures may be designed for mass production so that one design can fit and be comfortably and effectively used for a variety of different facial shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-produced patient interface, one or both must be accommodated to form a seal.

One type of seal-forming structure extends around the perimeter of the patient interface and is intended to seal against the patient's face when a force is applied to the patient interface, with the seal-forming structure engaging the face-facing of the patient. The seal-forming structure may comprise an air or fluid filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer such as rubber. For this type of seal-forming structure, if the fit is insufficient, there will be a gap between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face in order to achieve the seal.

Another type of seal-forming structure incorporates a flap seal of thin material positioned around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous forms of seal forming portions, if the fit between the face and mask is not good, additional force may be required to achieve the seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it may buckle or bend during use, resulting in leakage.

Another type of seal-forming structure may include friction-fit elements, for example, for insertion into nostrils, however some patients find these uncomfortable.

Another form of seal-forming structure may use an adhesive to effect the seal.

A series of patient interface seal formation construction techniques are disclosed in the following patent applications assigned to rismate limited (RESMED LIMITED): WO 1998/004,310; WO 2006/074,513; WO 2010/135,785.

One form of nasal pillow is found in Adam Circuit (Adam Circuit) manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Pat. No. 4,782,832 (Trimble et al) assigned to Puritan-Bennett corporation.

The following products in combination with nasal pillows have been manufactured by rismai limited: SWIFT ^TM nasal pillow mask, SWIFT ^TM II nasal pillow mask, SWIFT ^TM LT nasal pillow mask, SWIFT ^TM FX nasal pillow mask and MIRAGE LIBERTY ^TM full face mask. The following patent applications assigned to rismel limited describe examples of nasal pillow masks: international patent application WO 2004/073,778 (which describes other aspects of the SWIFT ^TM nasal pillow from Russian Mich.); U.S. patent application 2009/0044808 (which describes other aspects of the SWIFT ^TM LT nasal pillow of rismel limited); international patent applications WO 2005/063,328 and WO 2006/130,903 (which describe other aspects of the full face mask of MIRAGE LIBERTY ^TM, of Ruisimai Co., ltd.); international patent application WO 2009/052,560 (which describes other aspects of SWIFT ^TM FX nasal pillow, rismel limited).

1.2.3.1.2 Positioning and stabilization

The seal-forming structure of a patient interface for positive air pressure therapy is subjected to a corresponding force of air pressure to break the seal. Accordingly, various techniques have been used to position the seal-forming structure and maintain it in sealing relation with the appropriate portion of the face.

One technique is to use an adhesive. See, for example, U.S. patent application publication No. US2010/0000534.

Another technique is to use one or more straps and/or stabilizing straps. Many such harnesses present one or more of the problems of discomfort, bulkiness, discomfort, and inconvenience in use.

1.2.3.2 Respiratory Pressure Treatment (RPT) devices

Respiratory Pressure Therapy (RPT) devices may be used alone or as part of a system to deliver one or more of the above-described multiple therapies, such as by operating the device to generate an air stream for delivery to an airway interface. The flow of gas may be pressure controlled (for respiratory pressure therapy) or flow controlled (for flow therapy such as HFT). Thus, the RPT device may also be used as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

1.2.3.3 Air Loop

The air circuit is a conduit or tube constructed and arranged to allow air flow to travel between two components of the respiratory therapy system, such as the RPT device and the patient interface, in use. In some cases, there may be separate branches of the air circuit for inhalation and exhalation. In other cases, a single branched air circuit is used for inhalation and exhalation.

1.2.3.4 Humidifier

Delivering an air flow without humidification may result in airway dryness. The use of a humidifier with an RPT device and patient interface generates humidified gases, minimizing nasal mucosa desiccation and increasing patient airway comfort. Furthermore, in colder climates, warm air, which is typically applied to the facial area in and around the patient interface, is more comfortable than cold air.

1.2.3.5 Data management

There are many clinical reasons for obtaining data that determines whether a patient prescribed a respiratory therapy is "compliant," e.g., the patient has used his RPT device according to one or more "compliance rules. One example of a compliance rule for CPAP therapy is to require the patient to use the RPT device for at least 21 or 30 consecutive days, at least four hours per night, in order to consider the patient to be compliant. To determine patient compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data describing patient treatment using the RPT device, calculate usage over a predetermined period of time and compare to compliance rules. Once the healthcare provider has determined that the patient has used his RPT device according to compliance rules, the healthcare provider may inform the patient of the third portion of compliance.

Patient treatment has other aspects that may benefit from communication of treatment data with a third portion or external system.

Existing methods of communicating and managing such data may be one or more of the following: expensive, time consuming and error prone.

1.2.3.6 Vent technique

Some forms of treatment systems may include vents to allow removal of exhaled carbon dioxide. The vent may allow gas to flow from an interior space (e.g., plenum) of the patient interface to an exterior space of the patient interface, such as into the environment.

The vent may include an orifice and gas may flow through the orifice when the mask is in use. Many such vents are noisy. Others may clog during use, providing insufficient flushing. Some vents may disrupt sleep of the patient 1000 by, for example, noise or a concentrated air flow.

A number of improved mask ventilation techniques have been developed by rismate limited. See International patent application publication No. WO 1998/034,665; international patent application publication No. WO 2000/078,381; U.S. patent No. 6581594; U.S. patent application publication No. US2009/0050156; U.S. patent application publication No. US2009/0044808.

Noise meter of existing mask (ISO 17510-2:2007, pressure of 10cmH ₂ O at 1 m)

Only one sample, measured at 10cmH ₂ O using the test method specified in ISO 3744 in CPAP mode.

The sound pressure values of the various objects are listed below

1.2.4 Screening, diagnostic and monitoring System

Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary disease and typically involves a clinical specialist to apply the system. PSG typically involves placing 15 to 20 contact sensors on the patient in order to record various body signals, such as electroencephalograms (EEG), electrocardiography (ECG), electrooculography (EOG), electromyography (EMG), etc. PSG for sleep disordered breathing has involved two nights of patient observations in the clinic, namely one night for pure diagnosis and the second night for treatment parameters determined by the clinician. Thus, PSG is expensive and inconvenient. In particular, it is not suitable for home screening/diagnosis/monitoring of sleep disordered breathing.

Screening and diagnosis generally describes identifying a disorder from its signs and symptoms. Screening typically gives true/false results indicating whether the patient's SDB is severe enough to warrant further investigation, whereas diagnosis may yield clinically actionable information. Screening and diagnosis tend to be a one-time process, while monitoring of disease progression may continue indefinitely. Some screening/diagnostic systems are only suitable for screening/diagnosis, while some may also be used for monitoring.

Clinical professionals may be able to adequately screen, diagnose, or monitor patients based on visually observed PSG signals. However, there are situations where a clinical expert may not be available or where the clinical expert may not be affordable. Different clinical professionals may not agree on the patient's condition. Furthermore, a given clinical expert may apply different criteria at different times.

2 Summary of the invention

The present technology aims to provide medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders, which devices have one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

A first aspect of the present technology relates to an apparatus for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating, or preventing a respiratory disorder.

One aspect of certain forms of the present technology is to provide methods and/or devices that improve patient compliance with respiratory therapy.

One form of the present technique includes positioning and stabilizing structures to provide a force that maintains the seal-forming structure of the patient interface in a therapeutically effective position on the patient's head. The seal-forming structure is constructed and arranged to form a seal with an area of the patient's face surrounding an entrance to the patient's airway for delivering, in use, an air flow seal to at least the patient's nostrils at a therapeutic pressure of at least 6cmH ₂ O above ambient air pressure throughout the patient's respiratory cycle, the positioning and stabilizing structure comprising:

A headband portion comprising a first headband portion and a second headband portion, wherein the first headband portion and the second headband portion are connected by a seamless joint comprising at least one polymer layer spanning between and applied to the first headband portion and the second headband portion.

In the example: (a) Adjacent edges of the first headband portion and the second headband portion connected by the seamless joint may not overlap; (b) When the positioning and stabilizing structure is unloaded, adjacent edges of the first headband portion and the second headband portion connected by the seamless joint can abut; (c) In addition to the at least one polymer layer, adjacent edges of the first headband portion and the second headband portion can be directly connected together; (d) Adjacent edges of the first headband portion and the second headband portion may be welded together; (e) Adjacent edges of the first headband portion and the second headband portion are not directly connected.

In other examples: (a) The first headgear section and the second headgear section may be strap sections; (b) The first headband portion and the second headband portion may be headband conduit portions; (c) One of the first and second headband portions may be a strap portion and the other of the first and second headband portions may be a headband conduit portion; (d) One of the first and second headgear sections may be a strap connection tab section, and the other of the first and second headgear sections may be a headgear conduit section.

In other examples: (a) The at least one polymer layer surrounds the first headband portion and the second headband portion at the seamless joint; (b) The at least one polymer layer includes a first polymer layer applied to a first side of the first and second headband portions and a second polymer layer applied to a second side of the first and second headband portions.

In other examples: (a) the at least one polymer layer comprises an adhesive film material; (b) the at least one polymer layer comprises a thermoplastic material; (c) The at least one polymer layer comprises a thermoplastic elastomer material; (d) The at least one polymer layer comprises a material made of polyamide, polyester, polyethylene, polyurethane, polyolefin, vinyl, nylon, ethylene, or any suitable combination thereof; (e) the at least one polymer layer comprises a polyurethane material; (e) The at least one polymer layer comprises a thermoplastic polyurethane material.

In other examples: (a) Exposing the at least one polymer layer to processing conditions to secure the at least one polymer layer to the first headband portion and the second headband portion; (b) the treatment conditions include one or more of the following: increased heat or temperature conditions, increased pressure conditions, and/or radiation exposure conditions.

In other examples: (a) The at least one polymer layer overlaps each of the first headband portion and the second headband portion a minimum distance to resist a tension of at least 20N across the joint; (b) the minimum distance is about 3mm; (c) The at least one polymer layer overlaps each of the first headband portion and the second headband portion a minimum distance to resist a tension of at least 40N; (d) the minimum distance is about 5mm.

In other examples: (a) The at least one polymer layer may be used to impart different properties to the headband; (b) The at least one polymer layer may increase the stretchability of the headband on the joint; (c) The at least one polymer layer may impart shape retention properties to the headband; (d) The at least one polymer layer may impart increased rigidity to at least a portion of the headband.

In further examples, at least one of the first headband portion and the second headband portion is at least partially composed of a fabric material.

In an example, the positioning and stabilizing structure includes: (a) At least one gas delivery tube for receiving a flow of air from a connection port on top of the patient's head and delivering the flow of air to an inlet of the patient's airway via the seal-forming structure, the gas delivery tube being constructed and arranged to contact, in use, at least a region of the patient's head above an on-ear base of the patient's head, (b) the at least one gas delivery tube comprising a pair of headgear conduits for receiving a flow of air from a connection port on top of the patient's head and for delivering the flow of air to an inlet of the patient's airway via the seal-forming structure, each headgear conduit being constructed and arranged to contact, in use, at least one region of the patient's head above an on-ear base of the patient's head on a respective side of the patient's head; a headband strap. In an example, a flexible cover may be disposed over at least a portion of each headgear conduit. In an example, the flexible cover comprises a fabric. In the example: (a) A seamless joint comprising at least one polymer layer may be disposed between a portion of the headgear catheter and a portion of the headgear strap; (b) A seamless joint comprising at least one polymer layer may be disposed between the first portion of the headgear catheter and the second portion of the headgear catheter.

In further examples, the headgear strap includes: 1) a ring strap portion having an upper portion configured to cover, in use, a parietal bone of a patient's head and having a lower portion configured to cover, in use, or lie below, the occipital bone of the patient's head, the ring strap portion defining a ring, 2) a pair of upper strap portions, each configured to be connected, in use, between the ring strap portion and the mask portion of the patient interface on a respective side of the patient's head above a nose bridge point, 3) a pair of lower strap portions, each configured to be connected, on a respective side of the patient's head below an above-the-ear base point, between the ring strap portion and the mask portion of the patient interface. In an example, a seamless joint comprising at least one polymer layer may be provided between two or more strap portions.

In further examples, the headgear strap includes: 1) A back strap portion configured to cover or underlie the occiput of the patient's head in use; 2) A pair of upper strap portions, each upper strap portion configured to be connected between the back strap portion and a corresponding headgear conduit on a respective side of the patient's head; and 3) a pair of lower strap portions, each lower strap portion configured to be connected between a back strap portion and a mask portion of the patient interface. In an example, a seamless joint comprising at least one polymer layer may be provided between two or more strap portions.

Another aspect of one form of the present technology is a patient interface comprising: a seal-forming structure constructed and arranged to form a seal with a region of a patient's face surrounding an entrance to the patient's airway for delivering, in use, an air flow seal to at least the patient's nostrils at a therapeutic pressure throughout the patient's respiratory cycle; and a positioning and stabilizing structure that provides a force that maintains the seal-forming structure in a therapeutically effective position on the head of a patient, wherein the positioning and stabilizing structure is substantially as described herein.

Another aspect of one form of the present technique is a patient interface that is molded or otherwise configured to have a peripheral shape that is complementary to the peripheral shape of the intended wearer.

One aspect of one form of the present technology is a method of manufacturing an apparatus.

One aspect of certain forms of the present technology is an easy-to-use medical device that is easy to use by persons who are not medically trained, by persons with limited dexterity and vision, or by persons with limited experience in using such types of medical devices.

One aspect of one form of the present technology is a portable RPT device that can be carried by a person, for example, in a person's home.

One aspect of one form of the present technology is a patient interface that can be cleaned in a patient's home, for example, in soapy water, without the need for specialized cleaning equipment. One aspect of one form of the present technology is a humidifier tub that may be cleaned in a patient's home, such as in soapy water, without the need for specialized cleaning equipment.

The described methods, systems, apparatus and devices may be implemented to improve the functionality of a processor, such as a processor of a special purpose computer, a respiratory monitor and/or a respiratory therapy apparatus. Furthermore, the described methods, systems, apparatuses, and devices may provide improvements in the art including automatic management, monitoring, and/or treatment of respiratory conditions, such as sleep disordered breathing.

Of course, some of these aspects may form sub-aspects of the present technology. Various aspects of the sub-aspects and/or aspects may be combined in various ways and also constitute other aspects or sub-aspects of the present technology.

Other features of the present technology will become apparent from the following detailed description, abstract, drawings, and claims.

Description of the drawings

The present technology is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings and in which like reference numerals refer to similar elements and in which:

3.1 respiratory therapy System

Fig. 1A shows a system that includes a patient 1000 wearing a patient interface 3000 in the form of a nasal pillow receiving a supply of positive pressure air from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and transferred to the patient 1000 along an air circuit 4170. A bed partner 1100 is also shown. The patient sleeps in a supine sleeping position.

Fig. 1B shows a system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask for the patient 1000 receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

Fig. 1C shows a system including a patient 1000 wearing a patient interface 3000 in the form of a full face mask, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side lying sleeping position.

3.2 Respiratory System and facial anatomy

Fig. 2A shows a schematic diagram of the human respiratory system including nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveoli, heart and diaphragm.

Fig. 2B shows a view of the upper airway of a human including the nasal cavity, nasal bone, extra-nasal cartilage, alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus and trachea.

Fig. 2C is a front view of a face with several surface anatomical features identified, including upper lip, upper lip red, lower lip, mouth width, inner canthus, nose wings, nasolabial folds, and corners of the mouth. Upper, lower, radially inward and radially outward directions are also indicated.

Fig. 2D is a side view of a head with several surface anatomical features identified, including inter-eyebrow, nasal bridge point, nasal protrusion point, sub-nasal point, upper lip, lower lip, on-chin point, nasal ridge, nasal wing apex, on-ear base point, and sub-ear base point. The up-down and front-back directions are also indicated.

Fig. 2E is another side view of the head. The approximate location of the frankfurt level and the nose lip angle are indicated. Coronal planes are also indicated.

Figure 2F shows a bottom view of a nose with several features identified, including the nasolabial folds, lower lips, upper lip reds, nostrils, subnasal points, small columns of nose, protruding nasal points, long axis of nostrils, and mid-sagittal plane.

Fig. 2G shows a side view of the nose skin feature.

Fig. 2H shows subcutaneous structures of the nose, including lateral cartilage, septal cartilage, alar cartilage, seedlike cartilage, nasal bone, epidermis, adipose tissue, frontal processes of the maxilla, and fibrous adipose tissue.

Fig. 2I shows a medial anatomic view of the nose, about a few millimeters from the median sagittal plane, showing, among other things, the medial foot of the septal cartilage and the alar cartilage.

Fig. 2J shows a front view of the skull, including the frontal, nasal and zygomatic bones. Turbinates, as well as maxilla and mandible, are also indicated.

Fig. 2K shows a side view of a skull with a head surface profile and several muscles. The following bone portions are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone and occipital bone. The chin bulge is also indicated. The following muscles are shown: two abdominal muscles, a chewing muscle, a sternocleidomastoid muscle and a trapezius muscle.

Fig. 2L shows a front-to-outside view of the nose.

3.3 Patient interface

Fig. 3A illustrates a patient interface in the form of a nasal mask in accordance with one form of the present technique.

Fig. 3B shows a schematic view of a cross section through a structure at a point. The outward normal at this point is indicated. The curvature at this point has a positive sign and has a relatively large amplitude when compared to the amplitude of curvature shown in fig. 3C.

Fig. 3C shows a schematic view of a cross section through a structure at a point. The outward normal at this point is indicated. The curvature at this point has a positive sign and has a relatively small amplitude when compared to the amplitude of curvature shown in fig. 3B.

Fig. 3D shows a schematic view of a cross section through a structure at a point. The outward normal at this point is indicated. The curvature at this point has a zero value.

Fig. 3E shows a schematic view of a cross section through a structure at a point. The outward normal at this point is indicated. The curvature at this point has a negative sign and a relatively small amplitude when compared to the curvature amplitude shown in fig. 3F.

Fig. 3F shows a schematic view of a cross section through a structure at a point. The outward normal at this point is indicated. The curvature at this point has a negative sign and a relatively large amplitude when compared to the curvature amplitude shown in fig. 3E.

Fig. 3G shows a cushion for a mask comprising two pillows. The outer surface of the pad is indicated. Indicating the edges of the surface. The dome region and saddle region are indicated.

Fig. 3H shows a cushion for a mask. The outer surface of the pad is indicated. Indicating the edges of the surface. The path on the surface between points a and B is indicated. The straight line distance between point a and point B is indicated. Two saddle regions and one dome region are indicated.

Fig. 3I shows a surface with a one-dimensional pore structure on the surface. The planar curve illustrated forms the boundary of a one-dimensional hole.

Fig. 3J shows a cross section through the structure of fig. 3I. The surface shown defines a two-dimensional aperture in the structure of fig. 3I.

Fig. 3K shows a perspective view of the structure of fig. 3I, including two-dimensional holes and one-dimensional holes. The surface defining the two-dimensional aperture in the structure of fig. 3I is also shown.

Fig. 3L shows a mask with an inflatable bladder as a cushion.

Fig. 3M shows a section through the mask of fig. 3L and shows the inner surface of the balloon. The inner surface defines a two-dimensional aperture in the mask.

Fig. 3N shows another cross-section through the mask of fig. 3L. The inner surface is also indicated.

Fig. 3O shows a left hand rule.

Fig. 3P shows the right hand rule.

Fig. 3Q shows the left ear, including the left ear spiral.

Fig. 3R shows the right ear, including the right ear spiral.

Fig. 3S shows a right-hand spiral.

Fig. 3T shows a view of the mask including a sign of torsion of the spatial curve defined by the edges of the sealing film in different regions of the mask.

Fig. 3U shows a view of the plenum chamber 3200, showing the sagittal plane and the intermediate contact plane.

Fig. 3V shows a view of the rear of the plenum of fig. 3U. The direction of the view is perpendicular to the intermediate contact plane. The sagittal plane in fig. 3V bisects the plenum into left and right sides.

Fig. 3W shows a section through the plenum of fig. 3V, the section being taken at the sagittal plane shown in fig. 3V. The "middle contact" plane is shown. The intermediate contact plane is perpendicular to the sagittal plane. The orientation of the intermediate contact plane corresponds to the orientation of the chord 3210, the chord 3210 lying in the sagittal plane and contacting the cushion of the plenum at only two points in the sagittal plane: an upper point 3220 and a lower point 3230. The intermediate contact plane may be tangential at the upper and lower points, depending on the geometry of the pad in this region.

Fig. 3X shows the location of the plenum chamber 3200 of fig. 3U in use on a face. When the plenum chamber is in the in-use position, the sagittal plane of the plenum chamber 3200 generally coincides with the median sagittal plane of the face. The intermediate contact plane generally corresponds to a 'face plane' when the plenum is in the use position. In fig. 3X, the plenum chamber 3200 is the plenum chamber of the mask and the upper point 3220 is located approximately on the nose bridge point and the lower point 3230 is located on the upper lip.

Fig. 3Y illustrates a patient interface in the form of a mask having a conduit headgear in accordance with one form of the present technique.

Figure 7A illustrates a first form of a seamless joint between two portions of a headband in accordance with one form of the present technology.

Figure 7B illustrates a second form of a seamless joint between two portions of a headband in accordance with one form of the present technique.

Figure 8A illustrates a cross-section of a seamless joint between two welded portions of a headband in accordance with one form of the present technique.

Figure 8B illustrates a cross-section of a seamless joint between two portions of a headband in a released state in accordance with one form of the present technique.

Figure 8C shows a cross section of a seamless joint wherein the two portions of the headband are pulled apart under tension.

Fig. 9A illustrates a positioning and stabilizing section 3300 in accordance with one form of the present technique.

Fig. 9B illustrates another form of positioning and stabilizing section 3300 in accordance with the present technique.

Fig. 10A illustrates another form of positioning and stabilizing section 3300 in accordance with the present technique.

Fig. 10B illustrates another form of patient interface including a positioning and stabilizing portion 3300 in accordance with the present technique.

Fig. 10C illustrates another form of patient interface including a positioning and stabilizing portion 3300 in accordance with the present technique.

3.4RPT device

Fig. 4A illustrates an RPT device in one form in accordance with the present technique.

Fig. 4B is a schematic diagram of an inflation path of an RPT device in accordance with one form of the present technique. The upstream and downstream directions are indicated with reference to the blower and patient interface. The blower is defined upstream of the patient interface and the patient interface is defined downstream of the blower, regardless of the actual flow direction at any particular moment. An article located in the inflation path between the blower and the patient interface is downstream of the blower and upstream of the patient interface.

3.5 Humidifier

Figure 5A shows an isometric view of a humidifier in one form in accordance with the present technique.

Figure 5B illustrates an isometric view of a humidifier in one form in accordance with the present technique, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

3.6 Respiratory waveform

Fig. 6A shows a typical breathing waveform model of a person while sleeping.

Description of the preferred embodiments

Before the present technology is described in more detail, it is to be understood that this technology is not limited to the particular examples described herein that may vary. It is also to be understood that the terminology used in the present disclosure is for the purpose of describing the particular examples discussed herein only and is not intended to be limiting.

The following description is provided with respect to various examples that may share one or more common characteristics and/or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. In addition, in any of the examples, any single feature or combination of features may constitute further examples.

4.1 Treatment

In one form, the present technique includes a method for treating a respiratory disorder that includes applying positive pressure to an airway inlet of a patient 1000.

In some examples of the present technology, a positive pressure air supply is provided to the nasal passages of the patient via one or both nostrils.

In some examples of the present technology, mouth breathing is restricted, constrained, or prevented.

4.2 Respiratory therapy System

In one form, the present technology includes a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may include an RPT device 4000 for supplying an air flow to the patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

4.3 Patient interface

In accordance with one aspect of the present technique, a non-invasive patient interface 3000, such as that shown in fig. 3A, includes the following functional aspects: seal forming structure 3100, plenum chamber 3200, positioning and stabilizing structure 3300, vents 3400, one form of connection port 3600 for connection to air circuit 4170, and forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround an entrance to the patient's airway in order to maintain a positive pressure at the airway entrance of the patient 1000. The sealed patient interface 3000 is thus suitable for delivery of positive pressure therapy.

As shown in fig. 3Y, a non-invasive patient interface 3000 in accordance with another aspect of the present technique includes the following functional aspects: seal forming structure 3000, plenum chamber 3200, positioning and stabilizing structure 3300, vent 3400, and one form of connection port 3600 for connection to an air circuit, such as air circuit 4170 shown in fig. 1A-1C. The plenum chamber 3200 may be formed from one or more modular components, in the sense that it or they may be replaced with different components (e.g., components of different sizes).

The unsealed patient interface 3800 in the form of a nasal cannula includes nasal oxygen cannulas 3810a, 3810b that can deliver air to respective nostrils of the patient 1000 via respective apertures in the tips thereof. Such nasal oxygen cannulae typically do not form a seal with the inner or outer skin surface of the nostril. Such types of interfaces result in one or more gaps that exist by design (intentional) in use, but they are generally not fixed in size such that they may vary unpredictably due to movement during use. Unlike other types of mask-based respiratory therapy systems, this can provide complex inflation variables for the respiratory therapy system when performing inflation control and/or evaluation. Air to the nasal oxygen cannula may be delivered through one or more air supply lumens 3820a, 3820b coupled with the nasal cannula type unsealed patient interface 3800. The lumens 3820a, 3820b lead from the nasal cannula type unsealed patient interface 3800 to the respiratory therapy device via an air circuit. The unsealed patient interface 3800 is particularly suited for delivering flow therapy, where the RPT device generates an air flow at a controlled flow rate rather than a controlled pressure. The "vent" or gap at the unsealed patient interface 3800 is a passage between the ends of the tips 3810a and 3810b of the nasal cannula type unsealed patient interface 3800 to atmosphere via the patient's nostrils through which excess air flow escapes to the ambient environment.

If the patient interface is unable to comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

A patient interface 3000 according to one form of the present technology is constructed and arranged to provide a supply of air at a positive pressure of at least 6cmH ₂ O relative to the ambient environment.

A patient interface 3000 according to one form of the present technology is constructed and arranged to provide a supply of air at a positive pressure of at least 10cmH ₂ O relative to the ambient environment.

A patient interface 3000 according to one form of the present technology is constructed and arranged to provide a supply of air at a positive pressure of at least 20cmH ₂ O relative to the ambient environment.

4.3.1 Seal formation Structure

In one form of the present technique, the seal forming structure 3100 provides a target seal forming region and may additionally provide a cushioning function. The target seal forming area is an area on the seal forming structure 3100 where sealing may occur. The area where the seal actually occurs-the actual sealing surface-may vary from day to day and from patient to patient within a given session, depending on a number of factors including, for example, the location where the patient interface is placed on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100.

In some forms of the present technology, the seal forming structure 3100 is constructed of a biocompatible material, such as silicone rubber.

The seal forming structure 3100 according to the present technology may be constructed of a soft, flexible and resilient material such as silicone.

In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure 3100 configured to correspond to a different size and/or shape range. For example, the system may include one form of seal forming structure 3100 that is suitable for large sized heads but not small sized heads, and another suitable for small sized heads but not large sized heads.

4.3.1.1 Sealing mechanism

In one form, the seal-forming structure includes a sealing flange that utilizes a pressure-assisted sealing mechanism. In use, the sealing flange may readily respond to system positive pressure in the interior of the plenum chamber 3200 acting on its underside to urge it into tight sealing engagement with the face. The pressure assist mechanism may act in conjunction with elastic tension in the positioning and stabilizing structure.

In one form, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange comprises a relatively thin member having a thickness of less than about 1mm, such as about 0.25mm to about 0.45mm, which extends around the perimeter of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the boundary edge of the plenum chamber 3200 and extends at least partially around the perimeter. The support flange is or includes a spring-like element and acts to support the sealing flange against buckling in use.

In one form, the seal-forming structure may include a compression seal portion or a gasket seal portion. In use, the compression seal or the gasket seal is constructed and arranged to be in compression, for example as a result of elastic tension in the positioning and stabilising structure.

In one form, the seal-forming structure includes a tensioning portion. In use, the tensioning portion is held in tension, for example by adjacent regions of the sealing flange.

In one form, the seal-forming structure includes a region having an adhesive or cohesive surface.

In some forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having an adhesive or bonding surface.

4.3.1.2 Nasal bridge or nasal ridge region

In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over a nasal bridge or ridge region of a patient's face in use.

In one form, the seal-forming structure includes a saddle region configured to form a seal over a nasal bridge region or nasal ridge region of a patient's face.

4.3.1.3 Upper lip region

In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over an upper lip region (i.e., upper lip) of the patient's face when in use.

In one form, the seal-forming structure includes a saddle region configured to form a seal over an upper lip region of a patient's face in use.

4.3.1.4 Chin region

In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the chin region of the patient's face when in use.

In one form, the seal-forming structure includes a saddle region configured to form a seal when used on a chin region of a patient's face.

4.3.1.5 Forehead area

In one form, the seal-forming structure forms a seal over a forehead region of a patient's face in use. In such forms, the plenum chamber may cover the eye in use.

4.3.1.6 Nasal pillows

In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or pillows, each constructed and arranged to form a seal with a respective nostril of the patient's nose.

A nasal pillow according to one aspect of the present technology includes: a frustoconical body having at least a portion thereof forming a seal on a bottom surface of the patient's nose; a handle; on the frustoconical floor and connecting the frustoconical to the flexible region of the stem. In addition, the nasal pillow attachment structure of the present technology includes a flexible region adjacent the base of the handle. The flexible regions may cooperate to facilitate a universal connection structure that is adaptable with relative movement of both displacement and angle between the frustoconical and nasal pillow connected structures. For example, the frustoconical position may be axially moved toward the stem-connecting structure.

4.3.2 Plenum

The plenum chamber 3200 has a perimeter shaped to complement the surface contour of an average human face in the area where the seal will be formed in use. In use, the boundary edge of the plenum chamber 3200 is positioned immediately adjacent to the adjacent surface of the face. The actual contact with the face is provided by the seal forming structure 3100. The seal forming structure 3100 may extend around the entire perimeter of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and seal forming structure 3100 are formed from a single sheet of homogeneous material.

In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes in use. In other words, the eye is outside the pressurized volume defined by the plenum chamber. Such forms tend to be less noticeable and/or more comfortable to the wearer, which may improve compliance with the treatment.

In some forms of the present technology, the plenum chamber 3200 is constructed of a transparent material (e.g., transparent polycarbonate). The use of transparent materials may reduce the occlusion of the patient interface and help improve compliance with the therapy. The use of transparent materials may help a clinician to see how the patient interface is positioned and functioning.

In some forms of the present technology, the plenum chamber 3200 is constructed of a translucent material. The use of translucent materials may reduce the prominence of the patient interface and help to improve compliance with the therapy.

4.3.3 Positioning and stabilization Structure

The seal-forming structure 3100 of the patient interface 3000 of the present technology may be maintained in a sealed state by a positioning and stabilizing structure 3300 when in use. The positioning and stabilizing structure 3300 may include and function as a "headgear" in that it engages the patient's head to maintain the patient interface 3000 in a sealed position.

In one form, the positioning and stabilizing structure 3300 provides a retention force that is at least sufficient to overcome the effect of positive pressure in the plenum chamber 3200 to lift off the face.

In one form, the positioning and stabilizing structure 3300 provides a retention force to overcome the force of gravity on the patient interface 3000.

In one form, the positioning and stabilizing structure 3300 provides retention as a safety margin to overcome potential effects of damaging forces on the patient interface 3000, such as accidental interference from tube drag or with the patient interface.

In one form of the present technique, a positioning and stabilizing structure 3300 is provided that is configured in a manner consistent with being worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a small profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the locating and stabilizing structure 3300 includes at least one strap that is rectangular in cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

In one form of the present technique, a positioning and stabilizing structure 3300 is provided that is configured to be less bulky and cumbersome to prevent a patient from lying in a supine sleeping position, with the back area of the patient's head on a pillow.

In one form of the present technique, a positioning and stabilizing structure 3300 is provided that is configured to be less bulky and cumbersome to prevent a patient from lying in a side sleep position, with a side region of the patient's head on a pillow.

In one form of the present technique, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between a front portion of the positioning and stabilizing structure 3300 and a rear portion of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and may be, for example, a flexible strap or a soft strap. The decoupling portion is constructed and arranged such that the presence of the decoupling portion prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal when the patient lays their head on the pillow.

In one form of the present technique, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the outer layer of fabric includes loop material for partial engagement with the hook material.

In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, e.g., elastically extendable. For example, the strap may be configured to be in tension when in use and direct the force to bring the seal-forming structure into sealing contact with a portion of the patient's face. In one example, the strap may be configured as a tie.

In one form of the present technique, the positioning and stabilizing structure includes a first strap constructed and arranged such that, in use, at least a portion of a lower edge of the first strap passes over an on-the-ear base of the patient's head and covers a portion of the parietal bone and not the occipital bone.

In one form of the present technology applicable to nasal only masks or to full face masks, the positioning and stabilizing structure includes a second strap constructed and arranged such that, in use, at least a portion of the upper edge of the second strap passes under the sub-aural base of the patient's head and covers or is located under the occiput of the patient's head.

In one form of the present technology applicable to nasal only masks or to full face masks, the positioning and stabilizing structure includes a third strap constructed and arranged to interconnect the first strap and the second strap to reduce the tendency of the first strap and the second strap to separate from each other.

In some forms of the present technology, the positioning and stabilizing structure 3300 includes a strap that is flexible and, for example, non-rigid. This aspect has the advantage that the strap makes the patient more comfortable to lie on while sleeping.

In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a strap configured to be breathable to allow moisture to be transmitted through the strap.

In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each positioning and stabilizing structure 3300 configured to provide retention forces to correspond to a different range of sizes and/or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large-sized heads, but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads, but not for large-sized heads.

4.3.3.1 Catheter headband

4.3.3.1.1 Catheter headband tube

In some forms of the present technology, the positioning and stabilizing structure 3300 includes one or more headgear tubes 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the airway of the patient, such as through the plenum chamber 3200 and the seal-forming structure 3100. In the form of the present technique illustrated in fig. 3Z, the positioning and stabilizing structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the plenum chamber 3200. The tube 3350 is configured to position and stabilize the seal-forming structure 3100 of the patient interface 3000 over an appropriate portion of the patient's face (e.g., nose and/or mouth) in use. This allows the conduit of the air circuit 4170 that provides the pressurized air flow to be connected to the connection port 3600 of the patient interface, the connection port 3600 being in a position other than the front of the patient's face, for example at the top of the patient's head.

In the form of the present technique shown in fig. 3Y, the positioning and stabilizing structure 3300 includes two tubes 3350, each tube 3350 being positioned on a different side of the patient's head in use and extending over a respective ear (above an on-the-ear base on the patient's head) through a respective cheek region to an elbow 3610 at the top of the patient's 1000 head. Such a form of technique may be advantageous because if the patient sleeps sideways on his head, and wherein one of the tubes 3350 is in a compressed state to block or partially block the flow of gas along the tube 3350, the other tube 3350 remains open to supply pressurized gas to the patient. In other examples of the technology, patient interface 3000 may include a different number of tubes, such as one tube, or two or more tubes. In one example where the patient interface has one tube 3350, a single tube 3350 is positioned on one side of the patient's head in use (e.g., across one cheek region), and the strap forms part of the positioning and stabilizing structure 3300 and is positioned on the other side of the patient's head in use (e.g., across another region) to help secure the patient interface 3000 to the patient's head.

In the technical form shown in fig. 3Y, two tubes 3350 are fluidly connected to each other at the upper end and to connection port 3600. In some examples, the two tubes 3350 are integrally formed, while in other examples, the tubes 3350 are formed separately, but are connected in use and may be separate, for example, for cleaning or storage. Where separate tubes are used, they may be indirectly connected together, for example each tube may be connected to a T-connector having two arms/branches fluidly connectable to a respective one of the tubes 3350, and a third arm or opening in the T-connector providing a connection port 3600 for fluid connection to the air circuit 4170 in use.

4.3.3.2 Specific examples of the present technology

One form of the present technique includes a positioning and stabilizing structure 3300 to provide a force that maintains the seal-forming structure of the patient interface in a therapeutically effective position on the patient's head. The seal-forming structure is constructed and arranged to form a seal with an area of the patient's face surrounding an entrance to the patient's airway for delivering, in use, an air flow seal to at least the patient's nostrils at a therapeutic pressure of at least 6cmH ₂ O above ambient air pressure throughout the patient's respiratory cycle, the positioning and stabilizing structure comprising a headgear section comprising a first headgear section and a second headgear section, wherein the first headgear section and the second headgear section are connected by a seamless joint comprising at least one polymer layer spanning between and applied to the first headgear section and the second headgear section.

In one form of the present technique, the polymeric layer includes a material adapted to engage a corresponding headband portion. In an example, the polymer layer may include a thermoplastic material. For example, at least one of the polymer layers comprises a thermoplastic elastomer material. For example, the at least one polymer layer comprises a thermoplastic polyurethane material. However, it should be understood that other suitable materials are also contemplated. For example, the at least one polymer layer may comprise a material made of polyamide, polyester, polyethylene, polyurethane, polyolefin, vinyl, nylon, ethylene, or any suitable combination thereof. Examples of suitable polymer layers include polymer heat seal seam tape manufactured by Bemis Associates, inc. These seam tapes are thermoplastic polymers which can be applied by means of commercially available taping machines and connecting elements formed from various materials, in particular textile materials.

The polymer layer may be applied to the headgear portion using known manufacturing techniques, such as exposure to processing conditions including one or more of the following: increased heat or temperature conditions, increased pressure conditions, and/or radiation exposure conditions. Typically, application of heat and/or pressure causes the polymer layer to soften or melt, thereby penetrating the material of the headband portion. Upon subsequent cooling, the polymer layer is firmly bonded to each headband portion, thereby holding the headband portions together. The choice or specification of material for the at least one polymer layer may depend on the substrate material to which it is to be provided. In particular, the polymer layer may be selected to have a lower softening point than the base material. In an example, the substrate material may be a fabric, such as a fabric composite of one or more of the following: nylon, polyethersulfone (PES), blend fabrics, cotton, polyester, and the like. For example, a polymeric heat-seal seam tape applied using a hot-pressing technique may be subjected to a temperature in the range of 100 ℃ to 150 ℃, a pressure in the range of 50psi to 100psi, and a duration in the range of 10 seconds to 60 seconds. For example, a polymeric heat sealed seam tape applied using a thermal welding technique may be subjected to temperatures in the range of 200 ℃ to 500 ℃, loads in the range of 50psi to 100psi, and air pressures in the range of 3psi to 8 psi.

In one form of the present technique, as shown in fig. 7A, a seamless joint 3370 may be formed between the first headband portion 3372 and the second headband portion 3374, wherein at least one polymer layer 3376 surrounds the first headband portion 3372 and the second headband portion 3374 at the seamless joint 3370, i.e., surrounds the first headband portion 3372 and the second headband portion 3374.

In an alternative form of the present technique, as shown in fig. 7B, a seamless joint 3370 may be formed between the first headband portion 3372 and the second headband portion 3374 with a first polymer layer 3376 applied to a first side of the first headband portion 3372 and the second headband portion 3374 and a second polymer layer 3376 applied to a second side of the first headband portion 3372 and the second headband portion 3374.

In one form of the present technique, as shown in fig. 8A, adjacent edges 3378 of the first headband portion 3372 and the second headband portion 3374 that are joined by a seamless joint 3370 are directly joined, such as by ultrasonic welding 3380.

In an alternative form of the present technique, as shown in fig. 8B and 8C, adjacent edges 3378 are not directly connected, i.e., are connected to polymer layer 3376 by an interconnection. In an example, when the positioning and stabilizing structure is unloaded, i.e., when the patient interface is not being worn and no associated tension is applied, the adjacent edges 3378 may substantially abut. In an example, the polymer layer 3376 may have elastic properties that allow the adjacent edges 3378 to be pulled apart under tension and return to their original position once released.

In one form of the present technique, the distance that the polymer layer 3376 overlaps each of the first and second headband portions 3372 and 3372 (i.e., the distance from the edge of the polymer layer 3376 to the nearest edge 3378 of the first and second headband portions 3372 and 3372) may be determined by the desired connection strength requirements, such as the ability to resist minimum tension. For example, the upper strap may have a lower tension than the lower strap.

In one example, the minimum distance that the overlapping portions on each portion resist tension of at least 20N across the joint may be about 3mm. In one example, the minimum distance that the overlapping portions on each portion resist tension of at least 40N across the joint may be about 5mm.

In one form of the present technique, at least one of the first headband portion and the second headband portion is at least partially constructed of a fabric material. The polymeric layer may help reduce fabric damage, particularly delamination, by avoiding (a) perforation of the fabric and (b) stress concentrations at the seam that occur when stretching, as compared to seam joints typically used to join textile or fabric materials. In addition, the seamless joints of the present technology can improve productivity and save labor costs (e.g., a sewing speed along a 50 inch straight seam of about 30-40 seconds as compared to about 20-25 seconds using the seamless joints of the present technology). The polymer layer may provide a flat, smooth outer surface to reduce friction against the user's skin (particularly the face) and improve comfort compared to a stitched joint, which may present raised ridges and create localized points of increased pressure against the skin. In addition, the seamless joints of the present technology may be stronger than the stitched equivalent, for example, may resist deformation even after being subjected to forces above 100N. The seamless joint of the present technology may also reduce the weight of the headband and thus provide greater comfort compared to conventional stitched seams.

In an example of the present technology, both the first headband portion 3372 and the second headband portion 3374 are strap portions. However, the seamless joint 3370 may be used to connect various components of a headband of different configurations, such as a headband conduit section.

4.3.3.2.1 Headband bandage

In one example of the present technique, as shown in fig. 9A, the positioning and stabilizing structure 3300 includes a headband having a loop strap portion 3340. The loop strap portion 3340 encircles the back side of the patient's head providing a secure anchor for other strap portions connected to the plenum chamber 3200. The loop strap portion 3340 may also be referred to as a crown, crown strap, back/back or halo.

In this example of the present technology, the loop strap portion 3340 of the positioning and stabilizing structure 3300 includes an upper portion 3302 and a lower portion 3304. The upper portion 3302 is in use against the patient's head, on the parietal bone of the patient's head. Lower portion 3304 is configured to rest against the patient's head above or below the occiput of the patient's head in use. As shown, the loop strap portion 3340 defines a loop.

In this example, loop strap portion 3340 includes a pair of overhead strap portions 3330. The overhead strap portions 3330 may be configured to connect to one another near the sagittal plane of the patient's head. In some examples, the two overhead strap portions 3330 may be connected directly, or via an intermediate connection portion 3332.

In this example, the loop strap portion 3340 includes a back strap portion 3334, the back strap portion 3334 being configured to cover or underlie the occiput of the patient's head in use.

In this example, the locating and stabilizing structure 3300 includes a pair of upper strap portions 3312. Each upper strap portion 3312 is configured to be connected between the ring strap portion 3340 and the plenum chamber 3200. In use, each of the upper strap portions 3312 is located beside the patient's head, on a respective side, above an on-the-ear base point of the patient's head.

In this example, the locating and stabilizing structure 3300 also includes a pair of lower strap portions 3322. Each of the lower strap portions 3322 is configured to be connected between the ring strap portion 3340 and the plenum chamber 3200. In use, each of the lower strap portions 3322 is located beside the patient's head, on the respective side, below the on-the-ear base point above the patient's head.

Each of the upper strap portion 3312 and lower strap portion 3322 may be connected to the plenum chamber 3200 directly or via the frame 3500 of the positioning and stabilizing structure 3300.

In accordance with one aspect of the present technique, a seamless joint 3370 may be used to connect the various strap portions.

Fig. 9B shows an example of a headband in the form of a two-point connector band 3300. The headgear includes at least one upper strap portion 3312. The upper strap portion 3312 may be configured to cover a cheek region of the patient's face, preferably an upper cheek region, and extend between the top of the patient's ear and the patient's eye. The headgear also includes at least one lower strap portion 3322. The lower strap portion 3322 may cover an area of the patient's head that is below and behind the patient's ears. The upper strap portion 3312 and lower strap portion 3322 are connected to the front strap portion 3324. In use, the upper strap portion 3312 and lower strap portion 3322 attach the front strap portion 3324 to the front of the patient's ear. In the illustrated embodiment, the headgear includes two upper strap portions 3312, two lower strap portions 3322, and two front strap portions 3324, one on each of the left and right hand sides of the patient's skull. Two front strap portions 3324 may be integrally formed with one end of the upper strap portion 3312 and one end of the lower strap portion 3322, respectively. In the illustrated embodiment, two upper strap portions 3312 are attached to the overhead strap portion 3330 and two lower strap portions 3322 are attached to the back strap portion 3334 (including in this example an upper back strap portion 3334a and a lower back strap portion 3334 b). The overhead strap portion 3330 is connected to the back strap portion 3334a by two rear connection portions 3336 and/or each upper strap portion 3312 is connected to the lower strap portion 3324 by a rear connection portion 3336.

Each front strap portion 3324 is connected or connectable to a connection portion that engages an interface portion of patient interface 3000, such as an ultra-compact full face mask configured to seal with the mouth and nose of a patient.

Fig. 10A shows an example of a headgear strap 3301, the headgear strap 3301 comprising a pair of upper headgear strap portions 3312, each upper headgear strap portion 3312 being configured to be connected to a respective headgear conduit 3350 of a locating and stabilizing structure 3330, the locating and stabilizing structure 3330 being located, in use, on a respective lateral side of the patient's head (see fig. 10B). Headgear strap 3301 further includes a pair of lower headgear strap portions 3322, each lower headgear strap portion 3322 configured to be connected to a plenum chamber 3200. The lower headgear strap portion 3322 may be connected directly to the plenum chamber 3200, or via the connector 3800, as shown.

The pair of upper strap portions 3312 are connected between the back strap portion 3334 and the corresponding headgear duct 3350. In this example, the upper strap portion 3312 is connected to an eyelet on tab 3320 of headgear guide 3500. The lower strap portion 3322 is connected between the back strap portion 3334 and the plenum chamber 3200, in this example via headgear clips 3323.

The back strap portion 3334, upper strap portion 3312, and lower headgear strap portion 3322 may be integrally formed. Headgear strap 3301 and its upper strap portion 3312, lower headgear strap portion 3322 and back strap portion 3334 may be formed by a single flat knitting process.

In accordance with one aspect of the present technique, the various strap portions of headgear strap 3301 may be connected using seamless joints 3370.

4.3.3.2.2 Catheter headband tube

In accordance with one aspect of the present technique, the components of the catheter headgear 3301 can be connected using a seamless joint 3370. As shown in fig. 10B, the headgear catheter 3350 includes an upper catheter portion 3362 and a lower catheter portion 3363. In an example, the connection between the upper conduit portion 3362 and the lower conduit portion 3363 may be provided using a seamless joint 3370.

In a further example, the headgear conduit 3350 may be connected at a joint 3903 at an upper portion of the patient's head. In an example, the headgear conduit 3350 may be connected at joint 3903 using a seamless joint 3370.

Fig. 10C illustrates one example of a catheter headband 3301, the catheter headband 3301 having a structure similar to that described with reference to fig. 3Y, and further having a flexible cover 3352 disposed over at least a portion of each catheter 3350. A flexible cover 3352 may be provided for at least a portion of each conduit 3350 that would otherwise contact the patient's face.

In an example, the flexible cover 3352 includes a fabric, such as a knitted fabric. Circular knitting or 3D knitting may be used to form the flexible cover 3310.

In the example shown in fig. 10C, the fabric back strap 3334 may be formed separately from the cover 3352 and may be connected to the cover 3352, for example, using a seamless joint 3370. Alternatively, a strap attachment structure such as tab 3320 (see, e.g., fig. 3Y and 10B) may be attached to cover 3352.

In an example, the various components and structures of the catheter headgear 3301 may include a fabric as described in PCT patent application No. PCT/AU2022/050773, the contents of which are incorporated herein by reference.

4.3.3.2.3 Impart performance to a headband

In accordance with one aspect of the present technique, the at least one polymer layer may be used to impart different properties to the headband.

In examples, the material and/or construction of the polymer layer may be used to provide or control one or more of the following: water permeability, and/or air permeability. This is particularly true for headgear straps.

In an example, the at least one polymer layer may increase the stretchability of the headband across the joint. In other examples, the at least one polymer layer may impart shape retention properties to the headband. In further examples, the at least one polymer layer may impart increased rigidity to at least a portion of the headband.

For example, the thickness of at least one polymer layer may be selected or applied to achieve desired characteristics. In other examples, the materials comprising the at least one polymer layer may be selected to achieve desired properties. In other examples, the shape and/or orientation of the at least one polymer layer is to achieve a desired characteristic.

In one form of the technique, different regions of the headband may include different characteristics in terms of stretch capability. An example of such a headband is disclosed in PCT patent publication No. WO2020261138A1, the contents of which are incorporated herein by reference. Another such example is disclosed in PCT patent publication No. WO2020170100A1, the contents of which are incorporated herein by reference.

In the example shown in fig. 9A, the headgear straps of the positioning and stabilizing structure 3300 may be stretchable. Advantageously, the upper strap portion 3312, lower strap portion 3322 and loop strap portion 3340 are stretchable. The stretchable nature of the loop strap portion 3340 of the positioning and stabilizing structure 3300 allows the loop strap portion 3340 to conform and mate with the back, side and upper surfaces of the patient's head in use. The stretchability in the upper strap portion 3312 and lower strap portion 3322 causes these strap portions to extend slightly in length to provide some release when the plenum chamber 3200 is pressurized. When the plenum chamber 3200 is under pressure in use, the volume of pressurized air within the plenum chamber 3200 urges the plenum chamber 3200 and the frame 3500 in a forward direction away from the patient's face. In order to maintain the plenum chamber 3200 and seal forming structure 3100 in sealing contact with the patient's face, the force from this pressure must be counteracted by tension in the headgear straps. The ability for the upper strap portion 3312 and lower strap portion 3322 to extend at least a small amount in length may make the patient interface 3000 more comfortable in such situations. In an example, this can be at least partially achieved using the seamless joints 3370 of the present technology.

In an example, portions of the positioning and stabilizing structure 3300 may have greater rigidity. For example, the back strap portion 3334 may be reinforced with at least one polymer layer. The stiffener may provide a high level of stability to the patient interface 3000 during use because the purpose of the back strap portion 3334 is to provide an anchor for other strap portions connected to the plenum chamber 3200 while pulling the plenum chamber 3200 under tension towards the patient's face. The rigidized portion may be substantially non-stretchable, or at least less stretchable than the other strap portions, but may still be bendable to conform to the curvature of the patient's head. The non-stretchability or low stretchability of the rigidized portion provides reinforcement to the back strap portion 3334, provides a stronger anchor, and results in a more stable positioning and stabilizing structure 3300.

In an example, a seamless joint 3370 at the joint of the upper strap portion 3312 and the loop strap portion 3340 may be used to provide additional stiffness because, in use, the upper strap portion 3312 is under tension and there is a relatively large area of strap material at the joint. Strengthening the connection helps provide a high level of stability to the patient interface 3000.

In the example shown in fig. 9B, the overhead strap portion 3330 may include relatively limited stretchability or stretchability to provide stability on and around the crown of the patient's skull. For example, the overhead strap portion 3330 has less stretchability (i.e., elongation per unit force) than some other portions of the headgear. The upper strap portion 3312 and front strap portion 3324 may also have limited stretch capability and preferably less stretchability than some other portions of the headgear. The upper strap portion 3312 may have limited stretch capability to provide stability over and around the patient's crown. The front strap portion 3324 may have limited stretch capability to maintain adjustment or provide stability at the interface. In other words, the top strap portion 3330, the upper strap portion 3312, and the front strap portion 3324 may be relatively rigid as compared to other straps of the headgear to maintain the shape of the headgear and help provide proper force and comfort to the patient's head. Accordingly, the top strap portion 3330, the upper strap portion 3312, and the front strap portion 3324 extend less distance per unit force than other strap portions including headgear. The headgear may be of a variety of sizes (e.g., small, medium, large) to conform to patients having a variety of head sizes. In this way, the overhead strap portion 3330, the upper strap portion 3312, and the front strap portion 3324 do not need to be stretched or deformed to meet the size requirements of different patients. In contrast, the overhead strap portion 3330, the upper strap portion 3312, and the front strap portion 3324 may provide stability and/or rigidity regardless of the size of the individual patient's head.

The back strap portion 3334 may include greater stretchability than the crown strap portion, the upper strap portion, and the front strap portion. The greater stretchability in this region of the headgear allows the headgear to accommodate patients with differently sized heads. The lower strap portion 3322 may have a relatively greater stretch capability (e.g., as compared to the upper strap portion 3312 and front strap portion 3312, back strap portion 3334, etc.), preferably with the greatest stretch as compared to the other portions of the headgear. Together, lower strap portion 3322 and back strap portion 3334 provide anterior/posterior flex to the headgear, although lower strap portion 3322 may also provide some superior/inferior flex (e.g., because lower strap portion 3322 extends in anterior/posterior and superior/inferior directions along the patient's head). In some embodiments, the headgear has sufficient elasticity to allow the headgear to be put on and taken off without untying the strap attachment portion 3305 or releasing the connection portion from the interface portion 3500. To put on and take off the headgear, the patient can pull the back of the headgear up and over the crown of the patient's head while the headgear remains connected to the interface 3500. The greater stretch ability of the back strap portion 3334 and the lower strap portion 3322 may help the patient put on and take off the headgear. In other words, the headgear (e.g., particularly the back strap portion 3334) may be pulled in a posterior direction such that it does not directly apply tension to the patient's head. The gap created between the back strap portion 3334 and the patient's head allows the back strap portion 3334 to move in an upward direction along the patient's head and eventually away from the patient's head. Stretching the back strap portions 3334 may also apply tension to the lower strap portions 3322 (e.g., stretching them). Stretching of the lower strap portion 3322 may help to maneuver the headgear around the patient's ear to minimize discomfort. Because the upper strap portion 3312 and the front strap portion 3324 may have little or no stretching ability (e.g., as compared to the lower strap portion 3322), the opening for the ear will not fully deform and clamp the ear of the patient when the patient removes the headgear.

The rear attachment portion 3336 may have a stretching capability between the lower strap portion 3322 and the upper strap portion 3312. The rear connection portion 3336 may be disposed in front/rear and up/down directions and can provide extension in both directions.

The rear attachment portion 3336 is preferably sufficiently stiff to provide stability around the crown. Some or all of the rear attachment portions 3336 may have a slightly greater stretch capability than the upper strap portion 3312 because if the lower strap portion 3322 and/or the back strap portion 3334 are not sufficiently stretched to enable the headgear to clean the patient's head, these portions may need to be stretched to help when the patient is donning and doffing the headgear. In particular, the rear attachment portion 3336 may provide an extension in a primarily vertical direction so as to provide additional extension from the lower and back strap portions 3334 to a primarily horizontal extension. In some embodiments, the lower region of the rear attachment portion 3336 includes a greater stretch capability (e.g., a greater stretch capability than the remainder of the rear attachment portion 3336).

In some examples, the area of the headgear with the greatest stretch capability is the area where the upper strap portion 3312, lower strap portion 3322, and back strap portion 3334 are connected. The combined stretch ability of these straps may provide the area with the ability to stretch to a maximum length. In other words, the convergence of the three stretchable straps allows the headgear to achieve a maximum total combined length extension (e.g., in the anterior/posterior and superior/inferior directions). One or more polymer layers may be used to affect this property.

In some embodiments, the headband may be formed from different segments having different stretching capabilities. The different segments may be joined together, for example, by using a seamless joint 3370 of the present technology, to help achieve these capabilities.

In some forms, the upper back strap 3334a may be inextensible or substantially inextensible. Thus, the upper back strap 3334a may not stretch or stretch the same amount as the lower back strap 3334 b.

In some forms, the lower back strap 3334b may provide stretchability to the positioning and stabilizing structure 3300. Stretching across lower back strap 3334b may increase the distance between each lower back strap portion 3322, and/or the diameter of the opening. In either case, stretching across the lower back strap 3334b may help patients with differently sized heads comfortably wear and take off the positioning and stabilizing structure 3300. When no force is applied, the lower back strap 3334b may return substantially to its original length such that the positioning and stabilizing structure 3300 remains substantially snug against the patient's head (e.g., self-adjusting) and may be repeatedly worn without damaging (e.g., permanently deforming) the elastic material.

Thus, a central portion of back strap portion 3334 (e.g., positioned near the occiput to contact the patient's head) may stretch less than the sides of back strap portion 3334. In some forms, the connection between the lower back strap 3334b and the lower back strap portion 3322 may stretch while the central region of the lower back strap 3334b remains relatively rigid through the connection with the upper back strap 3334 a. The overall length of the extension may be smaller (e.g., as compared to the unattached lower back strap 3334 b), but the lower back strap 3334b is still able to stretch to accommodate heads of various sizes.

In one example, a portion of the back strap portion 3334 may be rigid, such as having an increased thickness and/or a more rigid polymer layer. The rigidized portion may strengthen the back strap portion 3334. The stiffener may provide a high level of stability to the patient interface 3000 during use because the purpose of the back strap portion 3334 is to provide an anchor for other strap portions connected to the plenum chamber 3200 while pulling the plenum chamber 3200 under tension towards the patient's face. The rigidized portion may be substantially non-stretchable, or at least less stretchable than the other strap portions, but may still be bendable to conform to the curvature of the patient's head. The non-stretchability or low stretchability of the rigidized portion provides reinforcement to the back strap portion 3334, provides a stronger anchor, and results in a more stable positioning and stabilizing structure 3300.

In the example shown in fig. 10A, at least a portion of the back strap portion 3334 of the headgear strap 3301 is rigidized to strengthen the back strap portion 3334. The stiffener may provide a high level of stability to the patient interface 3000 during use because the purpose of the back strap portion 3334 is to provide an anchor for other strap portions connected to the plenum chamber 3200 while pulling the plenum chamber 3200 under tension towards the patient's face. The rigidized portion may be substantially non-stretchable, or at least less stretchable than the other strap portions, but may still be bendable to conform to the curvature of the patient's head. The upper strap portion 3312 and lower strap portion 3322 may be stretchable and/or the seamless joint 3370 may provide a degree of stretch relative to the back strap portion 3334.

4.3.3.2.4 Surface finishing

In accordance with one aspect of the present technique, the at least one polymer layer may be provided with one or more surface finishes in accordance with desired aesthetic and/or functional features or characteristics.

In an example, the surface finish may include one or more of the following: coloring, lighting, patterns, shapes, textures, indicia.

In an example, at least one characteristic of the surface finish may be substantially the same as the surface finish of the material to which the at least one polymer layer is applied. For example, the surface finish may be selected to substantially match the surface finish of an adjacent surface so as to provide a substantially continuous feel to the user. In alternative embodiments, the surface finish may be different from the surface finish of the material to which the at least one polymer layer is applied.

In an example, the surface finish may be provided to the at least one polymer layer prior to producing the seamless joint. In an alternative example, the surface finish may be provided to the at least one polymer layer after the seamless joint is produced.

4.3.4 Vent

In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow for flushing of exhaled gases, such as carbon dioxide.

In some forms, the vent 3400 is configured to allow continuous venting flow from the interior of the plenum chamber 3200 to the ambient environment while the pressure within the plenum chamber is positive relative to the ambient environment. The vent 3400 is configured such that the vent flow has a magnitude sufficient to reduce re-breathing of exhaled CO2 by the patient while maintaining therapeutic pressure in the plenum in use.

One form of vent 3400 in accordance with the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

The vent 3400 may be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure, such as a rotator.

4.3.5 Decoupling structures

In one form, patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket.

4.3.6 Connecting ports

Connection port 3600 allows connection to air circuit 4170.

4.3.7 Forehead support

In one form, patient interface 3000 includes forehead support 3700.

4.3.8 Anti-asphyxia valve

In one form, the patient interface 3000 includes an anti-asphyxia valve.

4.3.9 Port

In one form of the present technique, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows the clinician to supply supplemental oxygen. In one form, this allows for direct measurement of gas properties, such as pressure, within the plenum chamber 3200.

4.4RPT device

An RPT device 4000 in accordance with one aspect of the present technology includes mechanical, pneumatic, and/or electrical components and is configured to execute one or more algorithms 4300, such as any of the full or partial methods described herein. RPT device 4000 may be configured to generate an air stream for delivery to an airway of a patient, such as for treating one or more respiratory conditions described elsewhere in this document.

4.4.1RPT device algorithm

As described above, in some forms of the present technology, the central controller 4230 may be configured to implement one or more algorithms 4300 represented as computer programs stored on a non-transitory computer-readable storage medium, such as memory 4260. Algorithm 4300 is typically grouped into groups called modules.

In other forms of the present technology, some or all of the algorithm 4300 may be implemented by a controller of an external device, such as the local external device 4288 or the remote external device 4286. In such forms, data representing the input signal and/or intermediate algorithm output required for the portion of algorithm 4300 executing at the external device may be transmitted to the external device via local external communication network 4284 or remote external communication network 4282. In such forms, portions of the algorithm 4300 to be executed at the external device may be represented as a computer program, such as having processor control instructions to be executed by one or more processors, stored in a non-transitory computer-readable storage medium accessible to a controller of the external device. Such a program configures the controller of the external device to execute the portion of the algorithm 4300.

In such forms, the therapy parameters generated by the external device via the therapy engine module 4320 (if so forming part of the algorithm 4300 executed by the external device) may be communicated to the central controller 4230 to be communicated to the therapy control module 4330.

4.5 Air Circuit

The air circuit 4170 in accordance with one aspect of the present technique is a tube or pipe constructed and arranged to allow air flow between two components, such as the RPT device 4000 and the patient interface 3000 or 3800, in use.

4.6 Humidifier

4.6.1 Overview of humidifier

In one form of the present technique, a humidifier 5000 (e.g., as shown in fig. 5A) is provided to vary the absolute humidity of the air or gas for delivery to the patient relative to ambient air. Generally, humidifier 5000 is used to increase the absolute humidity of the air stream and to increase the temperature of the air stream (relative to ambient air) prior to delivery to the airway of the patient.

The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air stream, and a humidifier outlet 5004 for delivering the humidified air stream. In some forms, as shown in fig. 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which may be adapted to receive the humidifier reservoir 5110 and include a heating element 5240.

4.7 Respiratory waveform

Fig. 6A shows a typical breathing waveform model of a person while sleeping. The horizontal axis is time and the vertical axis is respiratory flow. While parameter values may vary, a typical breath may have the following approximations: tidal volume Vt,0.5L, inspiration time Ti,1.6s, peak inspiratory flow Qpeak,0.4L/s, expiration time Te,2.4s, peak expiratory flow Qpeak, -0.5L/s. The total duration of respiration (Ttot) is about 4s. The person typically breathes at a breathing rate of about 15 Breaths Per Minute (BPM), with a ventilation of about 7.5L/min. A typical duty cycle (ratio of Ti to Ttot) is about 40%.

4.8 Respiratory treatment modes

Various respiratory therapy modes may be implemented by the disclosed respiratory therapy systems.

4.9 Glossary of terms

For purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of the present technology. In other forms of the present technology, alternative definitions may be applied.

4.9.1 General rules

Air: in certain forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, such as oxygen enriched air.

Environment: in certain forms of the present technology, the term environment is considered to mean (i) outside of the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

For example, the ambient humidity relative to the humidifier may be the humidity of the air immediately surrounding the humidifier, e.g. the humidity in a room in which the patient sleeps. Such ambient humidity may be different from the humidity outside the room in which the patient is sleeping.

In another example, the ambient pressure may be pressure immediately surrounding or external to the body.

In some forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room in which the patient is located, in addition to noise generated by, for example, an RPT device or from a mask or patient interface. Ambient noise may be generated by sound sources outside the room.

Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy, in which the treatment pressure is automatically adjustable between a minimum and maximum level, for example, varies with each breath, depending on whether an indication of an SBD event is present.

Continuous Positive Airway Pressure (CPAP) treatment: respiratory pressure therapy, wherein the therapeutic pressure is substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airway will be slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, e.g., increasing in response to detecting an indication of partial upper airway obstruction, and decreasing in the absence of an indication of partial upper airway obstruction.

Flow rate: air amount (or mass) delivered per unit time. Flow may refer to an instantaneous quantity. In some cases, the reference to flow will be a reference to a scalar, i.e., an amount having only a size. In other cases, the reference to flow will be a reference to a vector, i.e., a quantity having both magnitude and direction. Traffic may be given the symbol Q. Sometimes the 'flow' is abbreviated as 'flow' or 'gas flow'.

In an example of patient breathing, the flow may be nominally positive for the inspiratory portion of the patient's breathing cycle and thus negative for the expiratory portion of the patient's breathing cycle. The device flow Qd is the air flow leaving the RPT device. The total flow Qt is the flow of air and any supplemental gas to the patient interface via the air circuit. The ventilation flow Qv is the air flow leaving the ventilation port to allow flushing of the exhaled air. Leakage flow Ql is leakage flow from the patient interface system or elsewhere. Respiratory flow Qr is the flow of air received into the respiratory system of a patient.

Flow treatment: respiratory therapy involves delivering a flow of air to the entrance of an airway at a controlled flow rate known as the therapeutic flow rate, which is generally positive throughout the respiratory cycle of the patient.

A humidifier: the term humidifier will be considered to refer to a humidification device constructed and arranged or configured with physical structures capable of providing a therapeutically beneficial amount of water (H ₂ O) vapor to an air stream to improve the patient's medical respiratory condition.

Leakage: the word leakage will be considered as an unintended air flow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in a swivel elbow that leads to the environment.

Conductive noise (acoustic): conduction noise in this document refers to noise transmitted to the patient through the inflation path (such as the air circuit and patient interface and air therein). In one form, the conducted noise may be quantified by measuring the sound pressure level at the end of the air circuit.

Radiated noise (acoustic): radiation noise in this document refers to noise transmitted to the patient by the surrounding ambient air. In one form, the radiated noise may be quantified by measuring the acoustic power/pressure level of the object in question according to ISO 3744.

Ventilation noise (acoustic): ventilation noise in this document refers to noise generated by air flow through any vent, such as a vent of a patient interface.

Oxygen enriched air: air having an oxygen concentration greater than the oxygen concentration of atmospheric air (21%), such as at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. "oxygen-enriched air" is sometimes referred to simply as "oxygen".

Medical oxygen: medical oxygen is defined as oxygen-enriched air having an oxygen concentration of 80% or more.

Patient: a person, whether or not they have a respiratory disorder.

Pressure: force per unit area. The pressure can be expressed in units of range, including cmH ₂O、g-f/cm² and hectopascal (hPa). 1cmH ₂ O is equal to 1g-f/cm2 and is approximately 0.98 hPa (1 hPa=100 Pa=100N/m2=1 mbar-0.001 atm). In this specification, unless otherwise indicated, pressures are given in cmH ₂ O.

The pressure in the patient interface is given by the symbol Pm and the therapeutic pressure, which represents the target value obtained by the interface pressure Pm at the current moment, is given by the symbol Pt.

Respiratory pressure treatment: the air supply is applied to the inlet of the airway at a therapeutic pressure that is generally positive relative to the atmosphere.

Breathing machine: mechanical means to provide pressure support to the patient to perform some or all of the work of breathing.

4.9.1.1 Material

Silicone or silicone elastomer: synthetic rubber. In the present specification, reference to silicone refers to Liquid Silicone Rubber (LSR) or Compression Molded Silicone Rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under the trademark herein) manufactured by Dow Corning corporation (Dow Corning). Another manufacturer of LSR is the Wacker group (Wacker). Unless specified to the contrary, exemplary forms of LSR have a shore a (or type a) indentation hardness ranging from about 35 to about 45 as measured using ASTM D2240.

Polycarbonate: is a transparent thermoplastic polymer of bisphenol A carbonate.

4.9.1.2 Mechanical Properties

Rebound resilience: the ability of a material to absorb energy when elastically deformed and release energy when unloaded.

Elasticity: substantially all of the energy will be released upon unloading. Including, for example, certain silicones and thermoplastic elastomers.

Hardness: the ability of the material itself to resist deformation (e.g., described by young's modulus or indentation hardness scale measured on a standardized sample size).

The "soft" material may comprise silicone or thermoplastic elastomer (TPE) and may be easily deformed, for example, under finger pressure.

"Hard" materials may include polycarbonate, polypropylene, steel, or aluminum, and may not readily deform, for example, under finger pressure.

Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load may be a force or moment, such as compression, tension, bending or torsion. The structure or component may provide different resistances in different directions. The inverse of stiffness is the compliance.

Flexible structures or components: when allowed to support its own weight for a relatively short period of time, such as 1 second, a structure or component that changes shape (e.g., bends) will change.

Rigid structures or components: a structure or component that does not substantially change shape when subjected to loads typically encountered in use. An example of such use may be to place and maintain a patient interface in sealing relationship with an entrance to a patient airway, for example, at a pressure of about 20 to 30cmH ₂ O.

As an example, the I-beam may include a different bending stiffness (resistance to bending loads) in the first direction as compared to the second orthogonal direction. In another example, the structure or component may be flexible in a first direction and rigid in a second direction.

4.9.2 Patient interface

Anti-asphyxia valve (AAV): by opening to the atmosphere in a fail safe manner, the risk of excessive CO2 rebreathing of the patient is reduced.

Bending pipe: an elbow is an example of a structure that directs the axis of an air stream traveling therethrough to change direction through an angle. In one form, the angle may be about 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have an approximately circular cross-section. In another form, the elbow may have an oval or rectangular cross-section. In some forms, the elbow may be rotatable relative to the mating component, for example about 360 degrees. In some forms, the elbow may be removable from the mating component, for example, via a snap-fit connection. In some forms, the elbow may be assembled to the mating component via a single snap during manufacture, but not removable by the patient.

A frame: a frame will be considered to mean a mask structure that carries the tension load between two or more connection points with the headgear. The mask frame may be a non-airtight load bearing structure in the mask. However, some forms of mask frames may also be airtight.

Functional dead zone: (description to be inserted here)

A headband: the headband will be considered to mean a form of positioning and stabilizing structure designed for use on the head. For example, the headgear may include a set of one or more supports, straps, and reinforcements configured to position and hold the patient interface in place on the patient's face to deliver respiratory therapy. Some laces are formed from a laminate composite of a soft, flexible, resilient material, such as foam and fabric.

Film: a film will be considered to mean a typically thin element that is preferably substantially free of bending resistance but stretch resistant.

A plenum chamber: the mask plenum chamber will be considered to mean that portion of the patient interface having a wall at least partially enclosing a volume of space having air pressurized therein to above atmospheric pressure in use. The shell may form part of the wall of the mask plenum chamber.

And (3) sealing: may refer to the noun form of the structure (seal) or the verb form of the effect (seal). The two elements may be constructed and/or arranged to 'seal' or to achieve a 'seal' therebetween without the need for a separate 'seal' element itself.

A shell: the housing will be considered to mean a curved and relatively thin structure having a bendable, stretchable and compressible stiffness. For example, the curved structural wall of the mask may be the shell. In some forms, the housing may be multi-faceted. In some forms, the housing may be airtight. In some forms, the housing may not be airtight.

Reinforcement: a reinforcement will be considered to mean a structural component designed to increase the bending resistance of another component in at least one direction.

And (3) supporting: the support will be considered as a structural component designed to increase the resistance to compression of another component in at least one direction.

A rotating shaft: the sub-components of the component configured to rotate about a common axis are preferably independent, preferably at low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably includes a pair of mating cylindrical conduits. There may be little or no air flow leaking from the swivel during use.

Lacing (noun): a structure for resisting tension.

Vent port: (noun): allowing air flow from the mask interior or conduit to ambient air, such as for efficient flushing of exhaled air. For example, clinically effective flushing may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on mask design and treatment pressure.

4.10 Other remarks

A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the patent office document or the record, but otherwise reserves any copyright rights whatsoever.

Unless the context clearly indicates and provides a range of values, it is understood that every intermediate value between the upper and lower limits of the range, to one tenth of the unit of the lower limit, and any other stated or intermediate value within the range, is broadly encompassed within the present technology. The upper and lower limits of these intermediate ranges may independently be included in the intermediate ranges, and are also encompassed within the technology, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the stated limits, the present technology also includes ranges excluding either or both of those included limits.

Furthermore, where a value or values described herein are implemented as part of the present technology, it is to be understood that such value or values may be approximate unless otherwise stated, and that such value or values may be used for any suitable significant digit to the extent that practical technical implementation may allow or require it.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of exemplary methods and materials are described herein.

Obvious replacement materials with similar properties are used as alternatives to the specific materials identified for constructing the component. Moreover, unless specified to the contrary, any and all components described herein are understood to be capable of being manufactured and thus may be manufactured together or separately.

It must be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural equivalents thereof unless the context clearly dictates otherwise.

All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and/or materials which are the subject matter of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present technology is not entitled to antedate such disclosure by virtue of prior application. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.

The terms "include" and "comprising" are to be interpreted as: to each element, component, or step in a non-exclusive manner, indicating that the referenced element, component, or step may be present or utilized, or combined with other elements, components, or steps that are not referenced.

The topic headings used in the detailed description are for convenience only to the reader and should not be used to limit the topics that can be found throughout this disclosure or claims. The subject matter headings are not to be used to interpret the claims or the scope of the claims.

Although the technology has been described herein with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some instances, terminology and symbols may imply specific details that are not required to practice the technology. For example, although the terms "first" and "second" may be used, they are not intended to indicate any order, unless otherwise specified, but rather may be used to distinguish between different elements. Furthermore, while process steps in a method may be described or illustrated in a sequential order, such order is not required. Those skilled in the art will recognize that such sequences may be modified and/or aspects thereof may be performed simultaneously or even synchronously.

It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present technology.

Claims

1. A positioning and stabilizing structure that provides a force to maintain a seal-forming structure of a patient interface on a patient's head in a therapeutically effective position, the seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airway for delivering, in use, an air flow seal to at least the patient's nostrils at a therapeutic pressure of at least 6cmH ₂ O above ambient air pressure throughout the patient's respiratory cycle, the positioning and stabilizing structure comprising:

2. The positioning and stabilizing structure of claim 1, wherein adjacent edges of the first headband portion and the second headband portion connected by the seamless joint do not overlap.

3. The positioning and stabilizing structure of claim 2, wherein the adjacent edges of the first headband portion and the second headband portion connected by the seamless joint abut when the positioning and stabilizing structure is unloaded.

4. A positioning and stabilizing structure according to claim 2 or 3, wherein the adjacent edges of the first and second headband portions are directly connected together, except for the at least one polymeric layer.

5. The positioning and stabilizing structure of claim 4, wherein the adjacent edges of the first headband portion and the second headband portion are welded together.

6. A positioning and stabilizing structure according to claim 2 or 3, wherein the adjacent edges of the first headband portion and the second headband portion are not directly connected.

7. The positioning and stabilizing structure of any one of claims 1-6, wherein the first and second headgear sections are strap sections.

8. The positioning and stabilizing structure of any one of claims 1-6, wherein the first headband portion and the second headband portion are headband conduit portions.

9. The positioning and stabilizing structure of any one of claims 1-6, wherein one of the first and second headgear sections is a strap section and the other of the first and second headgear sections is a headgear conduit section.

10. The positioning and stabilizing structure of any one of claims 1-6, wherein one of the first and second headgear sections is a strap connection tab section and the other of the first and second headgear sections is a headgear conduit section.

11. The positioning and stabilizing structure of any one of claims 1-10, wherein the at least one polymer layer surrounds the first headband portion and the second headband portion at the seamless joint.

12. The positioning and stabilizing structure of any one of claims 1-10, wherein the at least one polymer layer comprises a first polymer layer applied to a first side of the first and second headband portions, and a second polymer layer applied to a second side of the first and second headband portions.

13. The positioning and stabilizing structure of any one of claims 1-12, wherein the at least one polymer layer comprises an adhesive film material.

14. The positioning and stabilizing structure of any one of claims 1-13, wherein the at least one polymer layer comprises a thermoplastic material.

15. The positioning and stabilizing structure of any one of claims 1-14, wherein the at least one polymer layer comprises a thermoplastic elastomer material.

16. The positioning and stabilizing structure of any one of claims 1-12, wherein the at least one polymer layer is exposed to processing conditions to secure the at least one polymer layer to the first headband portion and the second headband portion.

17. The positioning and stabilizing structure of claim 16, wherein the treatment conditions include one or more of: increased heat or temperature conditions, increased pressure conditions, and/or radiation exposure conditions.

18. The positioning and stabilizing structure of any one of claims 1-17, wherein the at least one polymer layer overlaps each of the first headband portion and the second headband portion a minimum distance to resist tension of at least 20N across the joint.

19. The positioning and stabilizing structure of claim 18, wherein the minimum distance is about 3mm.

20. The positioning and stabilizing structure of any one of claims 1-19, wherein the at least one polymer layer overlaps each of the first headband portion and the second headband portion a minimum distance to resist tension of at least 40N across the joint.

21. The positioning and stabilizing structure of claim 20, wherein the minimum distance is about 5mm.

22. The positioning and stabilizing structure of any one of claims 1-21, wherein the at least one polymer layer is used to impart different properties to the headband.

23. The positioning and stabilizing structure of any one of claims 1-22, wherein the at least one polymer layer increases the stretchability of the headband across the joint.

24. The positioning and stabilizing structure of any one of claims 1-23, wherein the at least one polymer layer imparts shape retention properties to the headband.

25. The positioning and stabilizing structure of any one of claims 1-24, wherein the at least one polymer layer imparts increased rigidity to at least a portion of the headband.

26. The positioning and stabilizing structure of any one of claims 1-25, wherein at least one of the first headband portion and the second headband portion is at least partially constructed of a fabric material.

27. The positioning and stabilizing structure of any one of claims 1 to 26, wherein the positioning and stabilizing structure comprises:

At least one gas delivery tube for receiving an air flow from a connection port on top of the patient's head and for delivering the air flow to the inlet of the patient's airway via the seal-forming structure, the gas delivery tube being constructed and arranged to contact, in use, at least one region of the patient's head above an on-ear base point of the patient's head,

Wherein the at least one gas delivery tube comprises a pair of headgear conduits to receive the flow of air from a connection port on top of the patient's head and deliver the flow of air to the inlet of the patient's airway via the seal-forming structure, each headgear conduit being constructed and arranged to contact, in use, on a respective side of the patient's head at least one region of the patient's head above an on-ear base point of the patient's head on a respective side of the patient's head; and

A band is worn.

28. The positioning and stabilizing structure of claim 27, wherein a seamless joint comprising at least one polymer layer is disposed between a portion of the headgear catheter and a portion of the headgear strap.

29. The positioning and stabilizing structure of claim 28, wherein a seamless joint comprising at least one polymer layer is disposed between the first portion of the headgear catheter and the second portion of the headgear catheter.

30. The positioning and stabilizing structure of any one of claims 27-29, comprising a flexible cover disposed over at least a portion of each headgear catheter.

31. The positioning and stabilizing structure of claim 30, wherein the flexible cover comprises a fabric.

32. The positioning and stabilizing structure of any one of claims 27 to 31, wherein the headgear strap includes:

A ring strap portion having an upper portion configured to cover, in use, the parietal bone of the patient's head and a lower portion configured to cover, in use, or underlie, the occiput of the patient's head, the ring strap portion defining a ring,

A pair of upper strap portions, each configured to be connected between the loop strap portion and a mask portion of the patient interface on a respective side of the patient's head above an on-ear base point in use,

A pair of lower strap portions, each configured to be connected between the loop strap portion and the mask portion of the patient interface on a respective side of the patient's head that is below the on-ear base point.

33. The positioning and stabilizing structure of any one of claims 27 to 31, wherein the headgear strap includes:

a back strap portion configured to cover, in use, the occiput of the patient or to underlie the occiput of the patient's head;

a pair of upper strap portions, each upper strap portion configured to be connected between the back strap portion and a respective headgear conduit on a respective side of the patient's head; and

A pair of lower strap portions, each lower strap portion configured to be connected between the back strap portion and a mask portion of the patient interface.

34. A patient interface, comprising:

a seal-forming structure constructed and arranged to form a seal with a region of a patient's face surrounding an entrance to the patient's airway for delivering, in use, an air flow seal to at least the patient's nostrils at a therapeutic pressure throughout the patient's respiratory cycle; and

A positioning and stabilizing structure that provides a force that maintains the seal-forming structure in a therapeutically effective position on a patient's head, wherein the positioning and stabilizing structure is in accordance with any one of claims 1 to 33.